VALIDAT Method Validation Lab Software

The simple and efficient solution for validation processes

Method validation is essential
If a new analytical method has been developed or modified, it is essential to validate this method. The systematic verification of the suitability of a method often requires a high expenditure of time and money, especially if the right tools are missing and the planning, verification and execution of all necessary steps are performed with different tools. This in turn requires elaborate review processes for validation. 

The planning of the examinations, avoiding duplicate examinations, is time-consuming. The distribution of tasks to the laboratories, persons and measuring instruments is time-consuming, and the manual subsequent compilation of the measurement results is error-prone. The statistical and graphical evaluations and the preparation of reports that are then necessary also require a great deal of effort.

 

For all these questions and activities of method validation the iCD offers a convincing software: VALIDAT. The market-leading method validation laboratory software VALIDAT with its mature and comprehensive functionality supports the tasks of method validation, from project planning to automatic evaluation and report generation. All validation projects of a company can be planned, processed and managed centrally, independent of the different methods. By means of report templates, all validation reports are automatically generated uniformly and stored centrally in the DMS.

This is how our method validation lab software VALIDAT can support you

For the successful implementation of your method validation projects, VALIDAT offers all mathematical and statistical procedures as well as full 21 CFR Part 11 compliance. Thanks to well-structured workflows and flexibly adaptable templates, the laboratory software VALIDAT organises your validation processes more easily and efficiently. A typical workflow is listed below:

Planning of a validation:
Planning can be carried out on the basis of an assistant and various templates. When opening a new project, information from an external system, such as a LIMS, can also be included. A revision of the project and also the electronic release with the corresponding audit trail are supported.

Carrying out the studies:
After the electronic release – as a starting point for processing – sequences can be transferred to a CDS (chromatography data system), to other measuring systems or to a LIMS, for example. In this way, the measurements required on the most varied samples are reduced to a minimum.

Recording of the measurement data:
In addition to the manual acquisition of the measurement data, they can also be automatically imported into VALIDAT. For this purpose, various measuring device interfaces or LIMS interfaces as well as an Excel interface are supported (see interfaces to VALIDAT).


Evaluation and reporting:
After all measurement data have been stored in VALIDAT, the statistical evaluation and the assessment of the results are carried out. A report can be generated at any time. The scope of the report (e.g. with the entire formula collection, images, measurement data etc.) as well as the appearance of the report is controlled by the report template. Every report and every change is documented in the integrated DMS. The report can also be exported as a Word document and edited independently of VALIDAT.

Your advantages at a glance

Proven laboratory software for method validation
The laboratory software VALIDAT supports the laboratory staff in all phases of the process of method validation, from planning and execution to evaluation and reporting. Various interfaces facilitate these activities. Transmission errors and unnecessary work are avoided. The past and future development of VALIDAT ensures that current and future requirements are met.

Significant time and cost savings
Up to 70% of the time is needed for manual method validation for planning, calculation, evaluation and reporting. This does not yet take into account that, especially in the regulated area, validation and qualification of the calculation and statistical evaluation as well as the preparation of reports is also necessary. This time-consuming work is not necessary when using VALIDAT.

Reduce risk through automated method validation
The entire workflow is supported by VALIDAT laboratory software through automated processes and the avoidance of manual data entry errors. Every change and status change is logged in the audit trail and is therefore traceable. Already during the planning stage, care is taken to ensure that the necessary information for statistical calculation is available. Transmission errors are avoided by the automatic provision of information for validation and the automatic transfer of measurement data. All calculations are validated. Deviations are indicated immediately throughout the entire process of method validation.